FDA 510(k) Application Details - K050676

Device Classification Name Gas-Machine, Anesthesia

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510(K) Number K050676
Device Name Gas-Machine, Anesthesia
Applicant DATEX-OHMEDA, INC.
P.O. BOX 7550
MADISON, WI 53707 US
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Contact DAN KOSEDNAR
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Regulation Number 868.5160

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Classification Product Code BSZ
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Date Received 03/16/2005
Decision Date 04/12/2005
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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